Pharma/fine chemicals roundup—10 December 2013

PCI Synthesis (Newburyport, MA), a manufacturer of new chemical entities (NCE), generic active pharmaceutical ingredients (APIs), complex pharmaceutical intermediates, and other specialty chemical products, has announced a list of trends that are likely to impact the generic drug and emerging biotech industries in 2014. The trends include increased regulatory scrutiny; drug shortages; wage inflation in India and China; a biotech bubble; and the challenge of finding qualified people.

Cambridge Major and AAIPharma appoint CFO of merged company

Cambridge Major Laboratories (CML; Germantown, WI), a producer of pharmaceutical intermediates and active pharmaceutical ingredients (APIs); and AAIPharma Services (Wilmington, NC), a provider of contract services that support all phases of drug development, say that they have appointed Eric Evans as the CFO of the merged company, AAI-CML. On 2 October, CML and AAIPharma announced their plans to merge. The merged company is a portfolio company of private equity firm American Capital (Bethesda, MD).

The Excipact Association, a project of the IPEC Federation (Brussels), says it has signed an agreement with DQS (Frankfurt, Germany), an internationally recognized certification body, for the certification of the manufacture and distribution of pharmaceutical excipients according to Excipact good manufacturing practice (GMP) and good distribution practice (GDP) certification standards. Auditors employed by DQS, who have completed Excipact training and have undertaken Excipact-witnessed audits of pharmaceutical excipient suppliers, will become certified auditors under the Excipact certification scheme. European Union and US pharmaceutical excipient regulations now require drug manufacturers to do either their own or third party physical audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance, Excipact says. Excipact is a voluntary international scheme to provide independent third party certification of manufacturers, suppliers and distributors of pharmaceutical excipients.

Ajinomoto completes expansion of capacity for amino acids for pharmaceutical use in China

Ajinomoto (Tokyo) says that its Shanghai Ajinomoto Amino Acid (Shanghai, China) subsidiary has completed the previously announced expansion of production capacity for amino acids for use in pharmaceuticals and foods. The newly expanded amino acid production line has become operational and the expansion of capacity to manufacture pharmaceutical-grade amino acids enables Ajinomoto meet demand in the steadily-growing global market, the company says.

Bayer bids to acquire Norwegian pharma company

The board of Algeta (Oslo) says it has received a preliminary acquisition proposal from Bayer. Bayer has offered to pay 336 Norwegian kroner ($54.68) per Algeta share, valuing the bid at $2.4 billion. Discussions are at an early stage, and further announcements may come, Algeta says. Bayer and Algeta are partners in Xofigo, which was approved by FDA in May for the treatment of castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Xofigo is the first alpha particle–emitting radioactive therapeutic agent approved by FDA. Algeta and Bayer HealthCare are copromoting the product in the United States. Bayer has licensed the full rights to Xofigo outside the US market.

Companies eyeing Novartis's animal health business

Several companies have emerged as potential buyers of Novartis’s animal health business, according to press reports. Novartis’s CEO, Joe Jimenez, said last month that the company may sell its nonstrategic animal health and OTC businesses if it cannot turn them into businesses of global scale. Combined revenues of the two businesses were $3.7 billion last year, 19% down on the year before. Novartis is working with Goldman Sachs on the review of its portfolio, according to Bloomberg. Bayer, which earlier this year acquired Teva Pharmaceutical’s veterinary business, is one of the interested parties, according to reports.

Druggability Technologies (DRGT; Dublin) says it has entered into a multiyear collaboration agreement with Bayer HealthCare that will deploy DRGT's proprietary Super-API platform in support of Bayer HealthCare's formulation efforts directed at improving compound solubility and bioavailability. DRGT's platform will be applied from early compound screening to clinical formulation of candidate drugs. The platform is expected to be applied across a range of compounds that are burdened by low solubility and poor bioavailability. “We believe that the application of our Super-API technology to the discovery and development portfolio of Bayer will help unlock the full potential of many drug candidates and can deliver clinically important benefits to patients,” says Gabor Heltovics, CEO of DRGT.

Beyond IHS Chemical Week:

Hospira: In-house API production to reach 50% by 2018 through acquisitions
from in-PharmaTechnologist.com